Standard Procedure Lip Balm SPF 50

Product NDC
84425-105
11-digit product format
844250105
Labeler code
84425
Product ID
84425-105_4862ec5d-eeef-2171-e063-6294a90ae506
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Homosalate Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
Standard Procedure Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
Substance
HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
60; 30; 80 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct84425-105DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage84425-10584425-105-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Standard Procedure Lip Balm SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE60 mg/mL
OCTOCRYLENE30 mg/mL
ZINC OXIDE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e3db995-b1c5-3a2e-e063-6294a90af75eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84425-105-05Standard Procedure Lip Balm SPF 505 mL in 1 TUBESTICK53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84425-105STANDARD PROCEDURE LIP BALM SPF 50 (ZINC OXIDE HOMOSALATE OCTOCRYLENE) STICK [STANDARD PROCEDURE INC]1Current NDC, 1 package rows20240821_1e3db995-b1c5-3a2e-e063-6294a90af75e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 52 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOjO Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d5ed865-fff2-ee44-e063-6294a90a67e22026-03-19WarningsExact identifier
application number: M020
ActivDerm Radiant Shield Broad Spectrum SPF 40ZINC OXIDEACTIVDERM LLC4d6307f1-bab6-5f44-e063-6294a90a8e362026-03-19WarningsExact identifier
application number: M020
Mad Robbit DEFEND SPF30SUNSCREENMAD RABBIT TATTOO, INC.bf853d54-ecd9-40cc-9f10-cb546bfb89332026-03-19WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREENZINC OXIDECLIO COSMETICS Co., Ltd.c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e2026-03-18WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLEZINC OXIDECOSMAX USA4d318f51-1a43-44d5-e063-6394a90a49702026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVEZINC OXIDECOSMAX USA4d319110-e6a4-1ad3-e063-6394a90aa99c2026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORALZINC OXIDECOSMAX USA4d31b201-9d6a-730a-e063-6394a90a67002026-03-17WarningsExact identifier
application number: M020
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
application number: M020
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84425-105-05844250105055 mL in 1 TUBE (84425-105-05) 5 ml2024-07-22NoNoCurrent